Duns Number:788403103
Device Description: The brand name for this component is IBC FloProbe and is part of the AcuFlo system of prod The brand name for this component is IBC FloProbe and is part of the AcuFlo system of products. This component is used in conjunction with the Medtronic Biomedicus Flow Pump System during open heart procedures. The IBC FloProbe is a direct product substitution for the Medtronic/Biomedicus Bioprobe, DP38.
Catalog Number
-
Brand Name
FloProbe 3/8" x 3/8” (Sterile)
Version/Model Number
3080S
Device Commercial Distribution Status
Not in Commercial Distribution
Commercial Distribution End Date
December 14, 2021
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
Yes
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
K963703
Product Code
DPT
Product Code Name
Probe, Blood-Flow, Extravascular
Public Device Record Key
1b763200-e9d9-49f7-ad66-59be492c8b74
Public Version Date
December 15, 2021
Public Version Number
4
DI Record Publish Date
June 18, 2016
Package DI Number
None
Quantity per Package
-
Contains DI Package
-
Package Discontinue Date
-
Package Status
-
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 2 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 22 |